Roche Attains European Recommendation for Retinal Vein Occlusion Treatment

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion to Roche extending its marketing authorization for Vabysmo (faricimab) to include treatment of visual impairment due to macular edema, secondary to retinal vein occlusion (RVO) (1). A press release from Roche on June 28, 2024 said the European Commission (EC) would be making a final decision on approval “in the near future,” though did not specify a date.

Vabysmo was earlier approved for RVO by FDA in October 2023 and the Japan Ministry of Health, Labour and Welfare in March 2024. It is also approved in nearly 100 countries around the world for those living with neovascular, or “wet,” age-related macular degeneration or diabetic macular edema (1).

Roche said RVO is the second-most common cause of vision loss when it comes to retinal vascular diseases, often sudden and severe, and affecting approximately 28 million adults worldwide, most age 60 and above (1). RVO itself is painless to the affected eye, as vein blockage restricts normal blood flow to the retina—resulting in macular edema, ischemia, bleeding, and fluid leakage—but is traditionally treated with a series of intravitreal injections of anti-vascular endothelial growth factor therapies. Vabysmo, if approved in Europe, would be the first bispecific antibody treatment for nearly 1 million people with RVO across the European Union, according to Roche.

“This CHMP recommendation represents an important step towards bringing Vabysmo to even more patients living with vision loss in Europe,” Levi Garraway, MD, PhD, Roche chief medical officer and head of global product development, said in the press release. “Recognizing the disruptive impact retinal vein occlusion can have on the everyday lives and independence of these patients, we hope that Vabysmo will offer a new treatment option that can effectively help preserve and improve their vision.”

CHMP’s decision followed the release of 72-week data from two Phase III students (BALATON, COMINO) that evaluated the performance of Vabysmo in more than 1200 patients with macular edema attributable to one of the two main types of RVO: branch RVO, when one of four smaller “branches” of the main central retinal vein is blocked, and the less common central RVO, when the central retinal vein itself becomes blocked (1,2,3). Both studies showed early, sustained vision improvements along with “robust” retinal drying, Roche said.

Current treatments for RVO are given every one to two months; the Vabysmo studies administered six monthly treatments over the first 20 weeks, then up to every four months from weeks 24 to 72 (1).

References

1. F. Hoffman-La Roche. Roche’s Vabysmo Gets CHMP Recommendation for Third Indication Retinal Vein Occlusion (RVO). Press Release. June 28, 2024.
2. ClinicalTrials.gov. Study Details | A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (BALATON). clinicaltrials.gov, Jan. 18, 2024 (accessed June 28, 2024). clinicaltrials.gov/study/NCT04740905
3. ClinicalTrials.gov. Study Details | A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion (COMINO). clinicaltrials.gov, Jan. 18, 2024 (accessed June 28, 2024). clinicaltrials.gov/study/NCT04740931